How the FDA is wrestling with bio-medical 3D-printing.

3D printing human heart

In a science-fictional universe way ahead of us in the future, there is no industrial complex as we know it today. No sprawling manufacturing campuses or security-patrolled warehouses crammed with shelved inventory. Everything we use on a day-to-day basis is created on demand, at the very moment it is required. All of our homes are […]

There’s Clean…and then there’s ‘Cleanroom Clean.’

Sterile SatPax

When it comes to cleanroom and controlled-environment news, the stories we read in the press can often be dramatic. Last week, we reviewed a dire situation with ebola where sub-standard gowns, gloves, and glove liners were jeopardizing the lives of medical personnel by allowing bodily fluids to permeate through to the wearer’s skin in a […]

When Standard Operating Procedures Aren’t Enough

Standard Operating Procedures

Although the FDA sometimes has a reputation as a stickler, it’s clear that the Food and Drug Administration often demonstrates a lot of patience, too—except when a company refuses to update their operating procedures to make required fixes to bring their standard operating procedures. Listen: we get it. No one likes to hear phrases like […]

Contamination Control News: It’s the Difference Between Life and Death

Ebola. Even that small collection of letters on a page is enough to strike fear into most people. And rightly so. In a recent outbreak of the disease in Liberia, a small West African nation bordered by Sierra Leone and Ivory Coast, ebola killed more than five hundred people. And while that in itself should […]

Contamination Control News: Compounding the Problem

Question of the Week: When does owning not one but two slick websites make up for the absence of ethics in aseptic processing? Answer: When it comes to a compounding pharmacy – never! Yet Professional Arts Pharmacy, a compounding pharmacy based in Baltimore, MD, seems to think that it does. With a confidence-inspiring main website […]

Contamination Control News: Examining the Scope of the Problem.

Scope of the problem

Imagine the scenario: after experiencing weeks of sudden and unexplained pain in your stomach, your doctor – suspecting ulcers – refers you to the hospital for tests. Or perhaps you rush your toddler to the ER after he swallowed part of his favorite action figure. In either of these cases, your immediate future involves getting […]

Contamination Control News: Do You Dare To Go Bare?

Taking of the Gloves

The food processing and healthcare industries are often linked in the media, and in the mind of the general public, for obvious and frequently deeply unpleasant reasons. And when stories break, they’re usually rooted in failures by the former that necessitate intervention by the latter. Let’s recall the recent case of the seafood processing plant […]

Contamination Control News: When Honey is Not So Sweet.

Compounding Pharmacies

In Lithuanian, the noun ‘Medaus’ translates as ‘honey,’ at once a description of nature’s superlative food and a term that’s come to describe something of excellent quality. ‘That’s one honey of a car!’ we might exclaim in admiration of our neighbor’s Jaguar, for example. But excellence is not what immediately springs to mind when reviewing […]

New Rules for Compounding Pharmacies in 2016

USP 797 Sampling Swabs

After a string on contamination issues in compounding pharmacies, the FDA has expanded some of it’s definitions and adopted some changes that seek to improve patient outcomes. One of the biggest changes in 2016 has been adopting a new broader definition of compounding which before was defined by Federal Food, Drug and Cosmetic Act which […]

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